FDA.reportPublic FDA data

CarboClear Hybrid Pedicle Screw System

Primary DI
07290117353547
Brand
CarboClear Hybrid Pedicle Screw System
Company
CARBOFIX ORTHOPEDICS LTD
Model
Set Screw
Catalog number
HYB4000
Device description
Set Screw for use as part of the CarboClear Hybrid Pedicle Screw System
Published
2024-07-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System
PMLBone Cement, Posterior Screw Augmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
PMLBone Cement, Posterior Screw AugmentationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240846000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240846000CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone CementCarboFix Orthopedics , Ltd.2024-04-25NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290117353544PackageGS12In Commercial Distribution
07290117353547PrimaryGS10
27290117353541Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729011735354417290117353544
07290117353547072901173535477290117353547
2729011735354127290117353541

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone set screwA small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).

Contacts#

Phone, Email table
PhoneEmail
1-800-408-0120usa@carbo-fix.com
+97299511511info@carbo-fix.com

Regulatory Flags#

DUNS number
649185170
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290117351024CarboClear Posterior Cervical Screw SystemDrill BitCS0122024-06-05
07290110209780CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5020N2021-06-29
07290110209797CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5025N2021-06-28
07290110209803CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5030N2021-06-28
07290110209810CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5035N2021-06-28
07290110209827CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5040N2021-06-28
07290110209834CarboClear X Pedicle Screw SystemPedicle Screw - Non CannulatedPNNS5045N2021-06-28
07290123860107CarboClear Posterior Cervical Screw SystemHybrid Angle AdjusterHCS062026-03-30
07290123860114CarboClear Posterior Cervical Screw SystemHybrid Counter TorqueHCS072026-03-30
07290117356869CarboClear Posterior Cervical Screw SystemSet ScrewHCS40002026-03-25
07290117356906CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40182026-03-25
07290117356913CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40202026-03-25
07290117356920CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40222026-03-25
07290117356937CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40242026-03-25
07290117356944CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40262026-03-25
07290117356951CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40282026-03-25
07290117356968CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40302026-03-25
07290117356975CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40322026-03-25
07290117356982CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40342026-03-25
07290117356999CarboClear Posterior Cervical Screw SystemHybrid ScrewHCS40362026-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493423166RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423173RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423180RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423197RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423203RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423210RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423227RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423234RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423241RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423258RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423265RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423272RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423289RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423296RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423302RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423319RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423326RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423333RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423340RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423357RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423364RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423371RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423388RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423395RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423401RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423418RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423425RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423432RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423449RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423456RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08